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Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01315093
Recruitment Status : Completed
First Posted : March 15, 2011
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens

Tracking Information
First Submitted Date  ICMJE March 8, 2011
First Posted Date  ICMJE March 15, 2011
Last Update Posted Date May 1, 2018
Study Start Date  ICMJE November 2010
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
no of oocytes retrieved [ Time Frame: egg recovery, 2 years ]
>2 between groups
Original Primary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
Οngoing pregnancy rate [ Time Frame: 12 weeks ]
The presence of fetal heart on ultrasound after 12 weeks of gestation
Change History Complete list of historical versions of study NCT01315093 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2016)
  • clinical pregnancy rate [ Time Frame: 2 years ]
    Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
  • live birth rate [ Time Frame: 2 years ]
    >20 weeks of gestation
  • cancellation rate [ Time Frame: before ET, 2 years ]
  • miscarriage rate [ Time Frame: 2 years ]
    pregnancy loss <20 weeks
Original Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2011)
Evidence and rate of clinical pregnancy [ Time Frame: 6+2 gestational weeks ]
Presence of fetal heart at transvaginal ultrasound at 6+2 gestational weeks
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Heparin in Poor Responders Undergoing In Vitro Fertilisation
Official Title  ICMJE Not Provided
Brief Summary The addition of heparin increases pregnancy outcome parameters in poor responders undergoing In Vitro Fertilisation (IVF)
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Infertility
Intervention  ICMJE
  • Drug: Heparin, Low-Molecular-Weight
    Heparin from start till hcg test
  • Drug: no heparin
Study Arms  ICMJE
  • Experimental: Heparin, Low-Molecular-Weight group
    LMWH was administered during an IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders. Drug was started at the beginning of the cycle and stopped at the time of pregnancy test if negative, or continued if pregnancy occurred until the 32th weeks of gestation
    Intervention: Drug: Heparin, Low-Molecular-Weight
  • Active Comparator: Non Heparin, Low-Molecular-Weight group
    IVF cycle using either the GnRH - agonist or antagonist protocol in poor responders.
    Intervention: Drug: no heparin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 6, 2016)
50
Original Estimated Enrollment  ICMJE
 (submitted: March 14, 2011)
100
Actual Study Completion Date  ICMJE June 2016
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • poor responders (age>40, abnormal ovarian test, </=4 oocytes in previous cycle with conventional stimulation)
  • infertility, indication for IVF
  • no contraindications for heparin
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 25 Years to 43 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Greece
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01315093
Other Study ID Numbers  ICMJE 123456
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Siristatidis Charalampos, MD, PhD, National and Kapodistrian University of Athens
Study Sponsor  ICMJE National and Kapodistrian University of Athens
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National and Kapodistrian University of Athens
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP